Guidewire devices having distally extending coils and shapeable tips

ABSTRACT

The present disclosure relates to guidewire devices having shapeable tips and effective torquability. A guidewire device includes a core having a proximal section and a tapered distal section. A tube structure is coupled to the core such that the tapered distal section of the core extends into and distally beyond the tube structure. The portion of the core extending distally beyond the tube forms a shapeable tip. One or more coils also extend distally beyond the tube. The tip is configured to reduce the tendency of resilient forces from the tube structure to disrupt a customized shape of the tip.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/611,328, filed Jun. 1, 2017 and titled “GUIDEWIRE DEVICES HAVINGDISTALLY EXTENDING COILS AND SHAPEABLE TIPS”, which claims priority toand the benefit of U.S. Provisional Patent Application Ser. No.62/363,760, filed Jul. 18, 2016 and titled “GUIDEWIRE DEVICES HAVINGSHAPEABLE TIPS”. The disclosures of each of the foregoing areincorporated herein by this reference.

BACKGROUND

Guidewire devices are often used to lead or guide catheters or otherinterventional devices to a targeted anatomical location within apatient's body. Typically, guidewires are passed into and through apatient's vasculature in order to reach the target location, which maybe at or near the patient's heart or neurovascular tissue, for example.Radiographic imaging is typically utilized to assist in navigating aguidewire to the targeted location. In many instances, a guidewire isleft in place within the body during the interventional procedure whereit can be used to guide multiple catheters or other interventionaldevices to the targeted anatomical location.

Some guidewire devices are constructed with a curved or bent tip toenable an operator to better navigate a patient's vasculature. With suchguidewires, an operator can apply a torque to the proximal end of theguidewire or attached proximal handle in order to orient and point thetip in a desired direction. The operator may then direct the guidewirefurther within the patient's vasculature in the desired direction.

Tuning the flexibility of a guidewire device, particularly the distalsections of the guidewire device, is also a concern. In manycircumstances, relatively high levels of flexibility are desirable inorder to provide sufficient bendability of the guidewire to enable theguidewire to be angled through the tortuous bends and curves of avasculature passageway to arrive at the targeted area. For example,directing a guidewire to portions of the neurovasculature requirespassage of the guidewire through curved passages such as the carotidsiphon and other tortuous paths.

Another concern related to guidewire devices is the ability of a givenguidewire device to transmit torque from the proximal end to the distalend (i.e., the “torquability” of the guidewire device). As more of aguidewire is passed into and through a vasculature passageway, theamount of frictional surface contact between the guidewire and thevasculature increases, hindering easy movement of the guidewire throughthe vasculature passage. A guidewire with good torquability enablestorqueing forces at the proximal end to be transmitted through theguidewire to the distal end so that the guidewire can rotate andovercome the frictional forces.

Some guidewire devices include a distally placed micro-machined hypotubepositioned over the distal end of the guidewire core in order to directapplied torsional forces further distally toward the end of the device.Because torsional forces are primarily transmitted through the outersections of a cross-section of a member, the tube is configured toprovide a path for increased transmission of torque as compared to theamount of torque transmitted by a guidewire core not sheathed by a tube.

While such guidewire devices have provided many benefits, severallimitations remain. For example, many of the design characteristics of aguidewire having a torque-transmitting tube, although functioning toprovide increased torque transmission, work against and limit theshapeability of the guidewire tip.

BRIEF SUMMARY

The present disclosure relates to guidewire devices having shapeabletips and effective torquability. In one embodiment, a guidewire deviceincludes a core with a proximal section and a distal section. The distalsection may taper to a smaller diameter than at the proximal section. Atube structure is coupled to the core such that the distal section ofthe core passes into the tube structure and passes distally beyond thetube structure to form a shapeable tip. The guidewire device alsoincludes an inner coil that encompasses at least a portion of the distalportion of the core. The inner coil is positioned such that a proximalportion of the inner coil is disposed between an outer surface of thecore and an inner surface of the tube structure, and such that a distalportion of the inner coil extends distally beyond the tube structure toencompass at least a portion of the shapeable tip. The guidewire devicealso includes an outer coil coupled to a distal end of the tubestructure and extending distally from the tube structure. The outer coilis positioned to encompass at least a portion of the inner coil. The tipis configured to reduce the tendency of resilient forces from the tubestructure to disrupt a customized shape of the tip.

In one embodiment, the core is formed from and/or includes stainlesssteel, the tube structure is formed from and/or includes a superelasticmaterial such as nitinol, the inner coil is formed from and/or includesa radiopaque material such as platinum, and the outer coil is formedfrom and/or includes stainless steel.

In some embodiments, the tube structure includes a plurality offenestrations that define a plurality of axially extending beamscoupling a plurality of circumferentially extending rings. The tubestructure may include one or more of a one-beam, two-beam, three-beamcut pattern, or cut pattern of more than three beams. In someembodiments, a rotational offset is applied between successive segmentsto minimize preferred bending directions along a length of the tubestructure.

Additional features and advantages will be set forth in part in thedescription that follows, and in part will be obvious from thedescription, or may be learned by practice of the embodiments disclosedherein. The objects and advantages of the embodiments disclosed hereinwill be realized and attained by means of the elements and combinationsparticularly pointed out in the appended claims. It is to be understoodthat both the foregoing brief summary and the following detaileddescription are exemplary and explanatory only and are not restrictiveof the embodiments disclosed herein or as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to describe the manner in which the above-recited and otheradvantages and features of the invention can be obtained, a moreparticular description of the invention briefly described above will berendered by reference to specific embodiments thereof which areillustrated in the appended drawings. Understanding that these drawingsdepict only typical embodiments of the invention and are not thereforeto be considered to be limiting of its scope, the invention will bedescribed and explained with additional specificity and detail throughthe use of the accompanying drawings in which:

FIG. 1 illustrates an exemplary embodiment of a guidewire deviceproviding effective torquability and having a shapeable tip;

FIG. 2 is a cross-sectional view of the guidewire device of FIG. 1;

FIGS. 3 through 8 illustrate various exemplary cut patterns that may beformed in the tube of the guidewire device; and

FIGS. 9 through 11 illustrate various distal tip configurations that maybe utilized with the guidewire device.

DETAILED DESCRIPTION Introduction

The present disclosure relates to guidewire devices providing effectiveanatomical navigation capabilities. The ability to steer and direct aguidewire to a targeted anatomical location depends on balancing andoptimizing tradeoffs between torquability and the ability to maintain ashaped tip. A guidewire device may include a shapeable tip to allow anoperator to point the tip in a desired direction within the vasculatureby rotating the distal tip. However, if the torquability of such aguidewire device is insufficient, the operator will be unable totransmit torsional forces all the way to the shaped distal tip tocontrol the orientation of the shaped distal tip. This hindrance willbecome increasingly problematic as the guidewire device is advancedfarther into the vasculature and experiences increasing frictionalresistance. In addition, if a guidewire device is unable to properlyform and maintain a shaped tip, it will have limited ability to adjusttip orientation, making intravascular navigation more difficult.

Embodiments described herein provide one or more features that balanceand/or optimize the relationship between guidewire torquability and theability to form and maintain a shaped tip. Such guidewires areresponsive to operator manipulation during guidewire deployment, andprovide effective navigation capabilities by enabling a shaped distaltip to receive transmitted torsional forces.

In some embodiments, the shapeable tip allows an operator to customshape the tip, such as by manually shaping the tip just prior todeploying the guidewire device within the patient's vasculature. Theoperator is thus enabled to customize the shaping of the distal tipaccording to preferences and/or conditions particular to a givenapplication. The guidewire device is also configured to effectivelytransmit torque while maintaining the shaped tip. At least someembodiments described herein include tips that are able to maintain abent or curved shape throughout a procedure, or throughout multipleprocedures, or even indefinitely until subjected to a counteractingreshaping force.

Guidewire Devices with Shapeable Tips

FIGS. 1 and 2 illustrate an exemplary guidewire device 100 having aneffective shapeable tip. FIG. 1 illustrates a side view of the deviceand FIG. 2 illustrates a cross-sectional view of the device. Theguidewire device 100 includes a core 102. A tube 104 is coupled to thecore 102 and extends distally from a point of attachment to the core102. As shown, a distal section of the core 102 extends into the tube104 and is surrounded by the tube 104. In some embodiments, the core 102includes one or more tapering sections so that the core 102 is able tofit within and extend into the tube 104. For example, the distal sectionof the core 102 may be ground so as to progressively taper to a smallerdiameter at the distal end. In this example, the core 102 and the tube104 have substantially similar outer diameters at the attachment point103 where they adjoin and attach to one another.

The tube 104 is coupled to the core 102 (e.g., using adhesive,soldering, and/or welding) in a manner that allows torsional forces tobe transmitted from the core 102 to the tube 104 and thereby to befurther transmitted distally by the tube 104. A medical grade adhesivemay be used to couple the tube 104 to the core wire 102 at one or morepoints (e.g., including attachment point 103). A medical gradeadhesive/polymer may also be used at the distal end of the device and toform an atraumatic covering 120.

As explained in more detail below, the tube 104 is micro-fabricated toinclude a plurality of cuts. The cuts are arranged to form a cut patternwhich beneficially provides for effective shapeability near the distaltip of the guidewire device 100 while also maintaining goodtorquability. For clarity, the cut pattern is not shown in FIGS. 1 and2. Examples of cut patterns which may be utilized in the tube 104 areshown in FIGS. 3 through 8.

In some embodiments, the proximal section 110 of the guidewire device100 extends proximally to a length necessary to provide sufficientguidewire length for delivery to a targeted anatomical area (not shown).The proximal section 110 typically has a length ranging from about 50 to300 cm (about 19.69 to 118.11 inches). The proximal section 110 may havea diameter of about 0.36 mm (about 0.014 inches), or a diameter within arange of about 0.20 to 3.175 mm (about 0.008 to 0.125 inches). Thedistal section 112 of the core 102 may taper to a diameter of about0.051 mm (about 0.002 inches), or a diameter within a range of about0.025 to 1.27 mm (about 0.001 to 0.050 inches). In some embodiments, thetube 104 has a length within a range of about 3 to 100 cm (about 1.18 to39.37 inches). The tube 104 may be formed from and/or include asuperelastic material such as nitinol. Alternatively, the tube 104 maybe formed from and/or include a linear elastic material (e.g., with arecoverable strain of at least about 6%). The portion of the deviceextending distally beyond the tube 104 (referred to as the tip 106) maymeasure about 0.5 to 5 cm in length, or about 1 to 3 cm in length.

In some embodiments, the distal section 112 of the core 102 tapers to around cross-section. In other embodiments, the distal section 112 of thecore 102 has a flat or rectangular cross-section. The distal section 112may also have another cross-sectional shape, such as another polygonshape, an ovoid shape, an erratic shape, or combination of differentcross-sectional shapes at different areas along its length.

Typically, a user will shape the distal end of the guidewire device 100by manually bending, twisting, or otherwise manipulating the distal 1 cmto 3 cm (approximately) of the guidewire device 100 to a desired shape.The illustrated guidewire device 100 includes a distal tip 106 whichextends distally beyond the tube 104. The tip 106 is configured to beshapeable so that an operator may manually bend, twist, or otherwisemanipulate the tip 106 to a desired shape. In some embodiments, the tip106 includes one or more shapeable components formed from stainlesssteel, platinum, and/or other shapeable materials. In preferredembodiments, the tip 106 includes one or more components formed from amaterial that exhibits work hardening properties, such that the tip,when shaped (i.e., plastically deformed), provides a higher elasticmodulus at the shaped sections than prior to being shaped.

An inner coil 114 is positioned partially within the tube 104 upon atleast a portion of the distal section 112 of the core 102. The innercoil 114 extends distally beyond the tube 104 to form part of the tip106. The inner coil 114 is preferably formed from one or more radiopaquematerials, such as platinum group, gold, silver, palladium, iridium,osmium, tantalum, tungsten, bismuth, dysprosium, gadolinium, and thelike. Additionally, or alternatively, the coil 114 may be at leastpartially formed from a stainless steel or other material capable ofeffectively holding shape after being bent or otherwise manipulated by auser.

In the illustrated embodiment, the inner coil 114 is disposed at or nearthe distal end of the device and extends a distance proximally towardthe attachment point 103. In the illustrated device, the majority of thelength of the inner coil 114 extends distally beyond the tube 104. Inother embodiments, the inner coil 114 may extend farther proximally. Theinner coil 114 may extend from the distal end by 1, 2, 4, 6, 8, 10, 12,15, 20, 25, 30, or 35 cm, or may extend a distance within a rangedefined by any two of the foregoing values.

In some embodiments, the section of the inner coil 114 extendingdistally beyond the tube 104 may be formed from a different materialthan more proximal sections of the inner coil 114. For example, thedistal section of the inner coil 114 may be formed from stainless steeland/or other materials primarily selected to provide effectiveshapeability, while the proximal sections of the inner coil 114 areformed from platinum or other materials primarily selected to provideeffective radiopacity. In some embodiments, the inner coil 114 is formedas one integral piece. In other embodiments, the inner coil 114 includesa plurality of separate sections positioned adjacent to one anotherand/or interlocked through intertwining coils. Such separate segmentsmay additionally or alternatively be soldered, adhered, or otherwisefastened to one another to form the complete inner coil 114.

Although the illustrated embodiment shows a space between the outersurface of the inner coil 114 and the inner surface of the tube 104, itwill be understood that this is done schematically for ease ofvisualization. In some embodiments, the inner coil 114 is sized to filland pack a greater proportion of the space between the core 102 and thetube 104. For example, the inner coil 114 may be sized so as to abutboth the outer surface of the core 102 and the inner surface of the tube104. Some embodiments may include a space between the core 102 and thetube 104 for at least a portion of the section of the guidewire device100 where the tube 104 and the core 102 are co-extensive.

The portion of the inner coil 114 disposed within the tube 104 maybeneficially function to pack the space between the core 102 and thetube 104 so as to align the curvature of the distal section 112 of thecore 102 with the curvature of the tube 104. For example, when acurvature is formed in the tube 104, the closely packed segments of theinner coil 114 function as a packing between the tube 104 and the distalsection 112 to impart the same curvature to the distal section 112. Incontrast, a core of a guidewire device omitting such packing, may notfollow the same curve as the tube but may extend until abutting againstthe inner surface of the tube before being forced to curve.

As shown, the tip 106 extends further distally than the tube 104. Theillustrated configuration beneficially allows the tip 106 to be shapedto a desired position relative to the tube 104 and the rest of theguidewire 100 and to remain in the shaped position for a sufficientlyextended period of time. In contrast to a guidewire device relying onshapeability of a tube or upon shapeable components disposed more fullywithin a tube, the illustrated tip 106 is able to maintain a shapedconfiguration without being subjected to counteracting forces impartedby the tube 104 itself.

In addition, as described more fully below, the tube 104 may include acut pattern which maintains effective torquability while also providingsufficient flexibility at the distal region of the tube 104 so as toavoid disrupting the custom shape of the tip 106. In preferredembodiments, the shapeable distal section of the core has a stiffnessthat is able to withstand an expected bending force from the tube actingupon the distal section of the core after it has been shaped. In someembodiments, the shapeable distal section of the core is formed from amaterial or combination of materials providing a modulus of elasticitythat is about 1.5 to 4 times greater, or about 2 to 3 times greater thanthe modulus of elasticity of the material(s) used to form the tube.

In contrast to the illustrated embodiments, a guidewire device whichrelies on shaping of a tube to provide a desired distal tip shape willnot be capable of holding the shaped configuration or will only becapable of holding the shaped configuration for a relatively shortperiod of time. This degradative effect on the shaped tip happens atleast in part because tube structures are typically formed from nitinolor other superelastic materials. Such tubes will be biased, upon beingbent or shaped, toward their original (e.g., straight) position, andwill impart recovery forces against any shapeable internal components,resulting in deformation and a loss of the customized shape of the tip.

Often, for example, a guidewire that distally terminates with a tubestructure or that otherwise substantially relies on bending of the tubestructure to shape the tip will have a shaped tip prior to deployment.However, the shaped tip will be lost or degraded during use of theguidewire as the superelastic tube flexes toward its original shape inopposition to the desired tip shape. In contrast, embodiments describedherein provide tips capable of being shaped without being subjected todeforming recovery forces of adjoining components of the guidewiredevice.

In the illustrated guidewire device 100, an outer coil 118 overlies thedistally extending section of the inner coil 114. The inner coil 114 andouter coil 118 may use similar or dissimilar coil characteristics (coilwire diameter, pitch, etc.). Typically, the outer coil 118 is formedfrom larger diameter coil wiring as compared to the wire diameter of theinner coil 114. The outer coil 118 may be formed from stainless steel orother suitable material capable of providing suitable shapeability.

Cut Patterns

FIGS. 3 through 8 illustrate exemplary embodiments of tube cut patternsthat may be utilized in one or more of the guidewire device embodimentsdescribed herein. For example, the tube 104 of the embodiment shown inFIGS. 1 and 2 may be cut according to one or more of the configurationsshown in FIGS. 3 through 8.

Cut patterns are referred to herein according to the number of axiallyextending beams disposed between each pair of adjacent circumferentiallyextending rings. FIGS. 3 and 4 illustrate “one-beam” cut patterns, FIGS.5 and 6 illustrate “two-beam” cut patterns, and FIG. 7 illustrates a“three-beam” cut pattern. Other embodiments may include more than threebeams between each pair of adjacent rings (e.g., a four-beam cutpattern, five-beam cut pattern, etc.).

The tube structure 304 illustrated in FIG. 3 includes a single beam 332disposed between each pair of adjacent rings 334. Pairs of adjacentbeams may alternate by 180 degrees, as shown. Additionally, oralternatively, sections may include beams positioned on a single sidealong a length of the tube, as shown by the beams 432 and rings 434 ofthe tube 404 of FIG. 4.

The tube structure 504 illustrated in FIG. 5 includes a pair ofcircumferentially opposing beams 532 disposed between each pair ofadjacent rings 534. The corresponding beams 532 in each pair may besymmetrically circumferentially spaced (i.e., by about 180 degrees) asshown by FIG. 5. Alternatively, the corresponding beams may becircumferentially non-symmetric, as shown by the beams 632 and rings 634of the tube 604 of FIG. 6. The tube structure 704 illustrated in FIG. 7includes a triad of beams 732 disposed between each pair of adjacentrings 734. The corresponding beams in each triad may be symmetricallycircumferentially spaced (i.e., by about 120 degrees) as shown, or maybe positioned according to some non-symmetric arrangement.

Generally, the higher the number of beams left between each pair ofadjacent rings, the relatively greater the stiffness of the tube. Cutpatterns may therefore be selected to provide a desired flexibilityprofile along the length of the tube. Cut spacing, width, and/or depthmay also be varied to provide desired flexibility characteristics. Forexample, one tube configuration can include a proximal section withrelatively lower flexibility and relatively higher torquability thatrapidly progresses to a distal section with relatively higherflexibility and relatively lower torquability. Beneficially, theflexibility provided by such cut patterns can minimize or prevent thetube from deforming the shape of the internal structures of theguidewire (e.g., the core) so that a customized shape of the tip can bebetter formed and maintained.

A section of tube having a two-beam cut pattern with substantiallycircumferentially equally spaced beams (as in FIG. 5) will typicallyhave relatively higher ability to transmit torque and relatively lowerflexibility, while a section of tube having non-symmetrically spacedbeams (as in FIG. 6) will typically have a torque transmissibility andflexibility between that of a symmetrically spaced beam pattern and aone-beam pattern. The less circumferentially symmetric the correspondingpair of beams are positioned, the closer together circumferentially theresulting beams will be, and therefore the more similar thenon-symmetric two-beam cut will be to a one-beam cut pattern. Such anon-symmetric two-beam pattern may therefore be used as a transitionbetween a symmetric two-beam pattern and a one-beam pattern.

The cut patterns may form “segments” of repeating structural units alonga length of the tube. In a typical one-beam embodiment, a single segmentcan be defined as a first beam 332 disposed between two adjacent rings334 (one proximal ring and one distal ring) and a second opposing beam332 extending from the distal ring and being rotationally offset byabout 180 degrees from the first beam 332. Likewise, in a typicaltwo-beam embodiment, a single segment can be defined as a first pair ofbeams 532 disposed between two adjacent rings 534 (one proximal ring andone distal ring) and a second pair of beams 532 extending from thedistal ring and being rotationally offset from the first pair of beamsby about 90 degrees. Likewise, in a typical three-beam embodiment, asingle segment can be defined as a first triad of beams 732 disposedbetween two adjacent rings 734 (one proximal ring and one distal ring)and a second triad of beams 732 extending from the distal ring and beingrotationally offset from the first triad by about 60 degrees.

FIG. 8 illustrates a tube 804 having a plurality of beams 832 and rings834. The illustrated cut pattern includes a rotational offset applied ateach successive segment of the tube 804 to minimize preferred bendingdirections in the tube. As used herein, a “rotational offset” is theangular rotation between two adjacent segments. A rotational offset istherefore applied from one segment to the next, even though individualcuts within a segment may also be offset from one another.

As shown, the cuts may be arranged to form a substantially consistentrotational offset from one segment to the next. The illustrated cutpattern shows a rotational offset of about 5 degrees from one segment tothe next. When multiple successive segments having such an angularoffset are formed, the resulting pattern of beams along a sufficientlength of the tube 804 wraps around the axis of the tube 804 in acontinuously rotating helical pattern. The angular offset may be about5, 15, 30, 45, 60, 75, 80, or 85 degrees. In some embodiments, theangular offset is applied at each successive segment. In otherembodiments, a plurality of successive segments are disposed next to oneanother without an offset before the angular offset is applied.

The illustrated example shows a two-beam cut pattern with a series ofrotational offsets. It will be understood, however, that the sameprinciples may be applied to other cut patterns, such as a one-beam cutpattern, three-beam cut pattern, or cut pattern having greater thanthree beams per pair of adjacent rings. In preferred embodiments, eachsuccessive cut or sets of cuts (e.g., every second cut, third, fourth,etc.) along the length of a given section is rotationally offset byabout 1, 2, 3, 5, or 10 degrees, or is offset by about 1, 2, 3, 5, or 10degrees off from 180 degrees in a one-beam pattern, 1, 2, 3, 5, or 10degrees off from 90 degrees in a two-beam pattern, 1, 2, 3, 5, or 10degrees off from 60 degrees in a three-beam pattern, and so on forpatterns having a higher beam count. These rotational offset values havebeneficially shown good ability to eliminate flexing bias.

The separate components and features of the cut patterns shown in FIGS.3 through 8 may be combined to form different tube configurations. Forexample, some tubes may be configured so as to have a section oftwo-beam cuts which transitions to a section of one-beam cuts.

Tip Variations

FIGS. 9 through 11 illustrate embodiments of various distal tipconfigurations that may be utilized with one or more of the embodimentsdescribed herein. FIG. 9 illustrates a continuous diameter tipconfiguration. Where the coil 918 surrounding the tapering core 902 hasa substantially continuous diameter. FIG. 10 illustrates a stepped tipconfiguration where an outer coil 1018 positioned over the core 1002 hasa substantially continuous diameter. A smaller diameter inner coil 1014is positioned so as to extend further distally than the outer coil 1018to provide a step-wise change in diameter of the tip. FIG. 11illustrates a tapered tip configuration where the coil 1118 is taperedso as to match a taper of at least a portion of the core 1102. The tipembodiments illustrated in FIGS. 9 through 11 may be combined with anyof the guidewire device embodiments described herein. For example, adesired tip configuration may be selected so as to provide desiredshapeability and/or flexibility characteristics for a given guidewireapplication.

The terms “approximately,” “about,” and “substantially” as used hereinrepresent an amount or condition close to the stated amount or conditionthat still performs a desired function or achieves a desired result. Forexample, the terms “approximately,” “about,” and “substantially” mayrefer to an amount or condition that deviates by less than 10%, or byless than 5%, or by less than 1%, or by less than 0.1%, or by less than0.01% from a stated amount or condition.

Elements described in relation to any embodiment depicted and/ordescribed herein may be combinable with elements described in relationto any other embodiment depicted and/or described herein. For example,any element described in relation to a tube section of any of FIGS. 3through 8 and/or any element described in relation to a tipconfiguration of any of FIGS. 9 through 11 may be combined and used withthe guidewire device of FIGS. 1 and 2. In any of the foregoingcombinations, the distal tip of the core wire may be rounded, flat, oranother shape.

The present invention may be embodied in other forms, without departingfrom its spirit or essential characteristics. The described embodimentsare to be considered in all respects only as illustrative and notrestrictive. The scope of the invention is, therefore, indicated by theappended claims rather than by the foregoing description. All changeswhich come within the meaning and range of equivalency of the claims areto be embraced within their scope.

What is claimed is:
 1. A guidewire device comprising: a core having aproximal section and a distal section, the distal section having asmaller diameter than the proximal section; a tube structure coupled tothe core such that the distal section of the core passes into the tubestructure and passes distally beyond the tube structure; an outer coilcoupled to a distal end of the tube structure and extending distallyfrom the tube structure; and an inner coil disposed within the tubestructure so as to be positioned between an outer surface of the coreand an inner surface of the tube structure, the inner coil beingconfigured in size and shape to abut both an outer surface of the coreand an inner surface of the tube structure.
 2. The guidewire device ofclaim 1, wherein the distal section of the core tapers from the proximalsection of the core.
 3. The guidewire device of claim 1, wherein theouter coil extends distally beyond the tube a distance of about 0.5 cmto 5 cm.
 4. The guidewire device of claim 1, wherein the outer coil isformed from a material that is more plastically deformable than nitinol.5. The guidewire device of claim 4, wherein the outer coil is formedfrom stainless steel.
 6. The guidewire device of claim 1, wherein aportion of the inner coil extends distally beyond the tube structure andis encompassed by the outer coil.
 7. The guidewire device of claim 1,wherein the inner coil is formed from a material more radiopaque thanstainless steel.
 8. The guidewire device of claim 7, wherein the innercoil is formed from platinum.
 9. The guidewire device of claim 1,wherein the tube structure is formed from nitinol.
 10. The guidewiredevice of claim 1, wherein the core is formed from stainless steel. 11.The guidewire device of claim 1, wherein the tube structure includes aplurality of fenestrations defining a plurality of axially extendingbeams coupling a plurality of circumferentially extending rings.
 12. Theguidewire device of claim 11, wherein the plurality of fenestrations arearranged into one or more of a one-beam cut pattern, two-beam cutpattern, or three beam-cut pattern.
 13. The guidewire device of claim11, wherein the fenestrations define a cut pattern with cuts ofincreasing depth toward a distal end of the tube structure and/or withspacing between successive cuts that decreases toward a distal end ofthe tube structure.
 14. The guidewire device of claim 1, wherein theinner coil and the outer coil are formed from different materials. 15.The guidewire device of claim 1, wherein the inner coil is formed from aradiopaque material and the outer coil is formed from a non-radiopaquematerial.
 16. A guidewire device comprising: a core having a proximalsection and a distal section, the distal section having a smallerdiameter than the proximal section; a tube structure coupled to the coresuch that the distal section of the core passes into the tube structureand passes distally beyond the tube structure; an inner coil disposed atleast partially within the tube structure and extending distally beyondthe tube structure; and an outer coil coupled to a distal end of thetube structure and extending distally from the tube structure, whereinthe outer coil encompasses at least a portion of the inner coilextending distally beyond the tube structure, wherein the inner coilextends farther distally than the outer coil.
 17. The guidewire deviceof claim 16, wherein the outer coil is formed from a material that ismore plastically deformable than nitinol, the inner coil is formed froma material more radiopaque than stainless steel, or both.
 18. Theguidewire device of claim 16, wherein the inner coil is configured insize and shape to abut both an outer surface of the core and an innersurface of the tube structure.
 19. A guidewire device comprising: a corehaving a proximal section and a distal section, the distal sectionhaving a smaller diameter than the proximal section; a tube structurecoupled to the core such that the distal section of the core passes intothe tube structure and passes distally beyond the tube structure; aninner coil disposed at least partially within the tube structure andextending distally beyond the tube structure, wherein the inner coilincludes different sections each formed from different materials; and anouter coil coupled to a distal end of the tube structure and extendingdistally from the tube structure, wherein the outer coil encompasses atleast a portion of the inner coil extending distally beyond the tubestructure.
 20. The guidewire device of claim 19, wherein a section ofthe inner coil extending distally beyond the tube structure comprises afirst material, and wherein a section of the inner coil disposed withinthe tube structure comprises a second, different material.